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Generic Version of Restless Legs Syndrome Drug Approved

A dopamine agonist used to treat restless legs syndrome — Requip (ropinirole hydrochloride) — has been approved in generic form, the FDA announced on Friday.

Other indications for Requip (for example, Parkinson disease) are still protected by patent. The generic's manufacturers may also seek approval for that indication once the patent expires later this month.

As with Requip, the generic equivalents will carry a warning about sudden somnolence during activities of daily living.

LINK(S):

FDA announcement (Free)

Requip label (Free PDF)

Published in Physician's First Watch May 12, 2008

Copyright © 2008. Massachusetts Medical Society. All rights reserved.